Prescription drug · ANDA
Sodium Phenylbutyrate (Sodium phenylbutyrate tablets, 500 mg) NDC 49884-170
Sodium phenylbutyrate 500 mg/1 · Tablet · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-170-04 | 49884017004 | 1 BOTTLE in 1 CARTON (49884-170-04) / 250 TABLET in 1 BOTTLEMarketed from Apr 29, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sodium Phenylbutyrate
- Generic name (nonproprietary)
- sodium phenylbutyrate tablets, 500 mg
- Active ingredients
- Sodium phenylbutyrate — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204395
- Marketing start
- Listing expires
- Other FDA classes
- Ammonium Ion Binding Activity (Mechanism)
- Identifiers
- Product ID 49884-170_2bf2608e-f953-4123-98f8-05122fd6e10dSPL ID 2bf2608e-f953-4123-98f8-05122fd6e10dSPL set ID 4020b962-eaee-4184-b04b-14ca757c51a1RxCUI 199369UNII NT6K61736TUPC 0349884170042
- Pharmacologic class
- Nitrogen Binding Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N449884017004followed by a unit qualifier and the quantityPackage 49884-0170-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Sodium Phenylbutyrate Tablets is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately to…
Excerpt only. Read the full label for complete information.
About NDC 49884-170
- What is NDC 49884-170?
- 49884-170 is the product NDC for Sodium Phenylbutyrate, Sodium phenylbutyrate 500 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Phenylbutyrate (Sodium Phenylbutyrate Tablets, 500 mg).
- What is the active ingredient?
- Sodium phenylbutyrate.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Phenylbutyrate?
- 4 other product NDCs are listed under this name. See all Sodium Phenylbutyrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Phenylbutyrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium phenylbutyrate | Sodium phenylbutyrate 500 mg/1 | TabletOral | Navinta LLC | 68475-011 | 68475-0011-01 |
| Sodium phenylbutyrate | Sodium phenylbutyrate 500 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-2180 | 70710-2180-08 |
| sodium phenylbutyrate | Sodium phenylbutyrate 500 mg/1 | TabletOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-853 | 68462-0853-20 |
| Sodium Phenylbutyrate | Sodium phenylbutyrate .94 g/g | PowderOral | Par Health USA, LLC | 49884-006 | 49884-0006-04 |